# K133673: Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit, Illumipro-10 Automated Isotherma

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Mar 25, 2014 after 116 days
- Product code: OZZ (Bordetella Pertussis Dna Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN070013 (2008). 7 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123620: Filmarray Respiratory Panel (RP), Biofire Diagnostics, Inc. (2013) Summary page 1.
- K120267: Filmarray RP Panel, Idaho Technology, Inc. (2012) Summary page 1.
- K110764: Filmarray RP Panel, Idaho Technology, Inc. (2011) Summary page 1.
- K103175: Filmarray Respiratory Panel (RP), Idaho Technology, Inc. (2011) Summary page 1.

## Most influential descendants
- K163626: ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit (2017), 2 descendants of its own
- K173498: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (2018), 1 descendant of its own
- K183223: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (2018), 0 descendants of its own
- K170284: Great Basin Bordetella Direct Test (2017), 0 descendants of its own
- K143206: AmpliVue Bordetella Assay (2014), 0 descendants of its own

## Indications for use
The illumigene® Pertussis DNA Amplification Assay, performed on the illumipro-IO™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis. The illumigene Pertussis assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Bordetella pertussis by targeting the IS481 insertional element of the Bordetella pertussis genome. The IS481 insertional element can also be found in Bordetella holmesii and Bordetella bronchiseptica strains. Respiratory infection with Bordetella pertussis, Bordetella holmesii or Bordetella bronchiseptica may yield positive test results in IS481 assays. B. holmesii infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines. Negative results for the illumigene Pertussis DNA Amplification Assay do not preclude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient's clinical evaluation as an aid in diagnosis of Bordetella pertussis infection and should not be used as the sole basis for treatment or other patient management decisions. illumigene Pertussis is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Source page: https://510kreport.com/device/K133673
Methodology: https://510kreport.com/methodology